Too much navel staring, too much fear, C-Pulse is the big one....

Too much navel staring, too much fear, C-Pulse is the big one.
1) C-Pulse is a really effective device. Hard to see how it could preform better.
Nothing this good (with the clinical data/results and backing science) has been seen like this before.
2) No hidden problem, the FDA sees every bit of data on every patient. Any hidden problem and they would stop the trial.
3) No competition.
4) a.Hypertension trials on the money.
b. Same for other potential markets
5) Fully implantable going well but working through its development and regulatory process. Doctors are experts in medicine not on the development/regulatory process which can be as frustrating for them as anyone.
6) Except for the time taken to approve restart of trial, positive relationship with FDA, i.e.SSH achieved "device related death" after due process.
7)Nothing untoward about CEO's departure. At the job for 6 yrs, device set up for next stage.
8) Clinicians impressed.

Ifs
1)Financing, not really, C-Pulse is the big one (bar a black swan event)
If Salverstone? can't sell this!!
2) Fast tracking for fully implantable, greatly assist cost and timeframe.
3) European reimbursement, who knows? weird process.